Augmedics earned FDA 510(k) clearance for X2, its new augmented reality headset for the xvision spine system, according to a Nov. 12 news release.
The new headset includes a detachable, surgical-grade headlight and a new lens tilt to support surgeons. It has enhanced technical and optical specifications, and an AR display has a 100% increase in surgeon field of view.
“Augmedics was a pioneer in the field with the first AR guidance system to be used in surgery. We have continued to be a leader in the space with more than 12,000 patients treated with our first-generation technology,” Augmedics President and CEO Paul Ziegler, said in the release. ““With that foundation established, we’re entering a new era in Augmedics history. X2 is a significant step forward and represents a proprietary platform for long-term procedural innovation.”
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